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MSD receives fourth Breakthrough Therapy Designation for Keytruda

MSD (NYSE: MRK) has announced that the US Food and Drug Administration has granted Breakthrough Therapy Designation to Keytruda (pembrolizumab) for the treatment of patients with relapsed or refractory classical Hodgkin lymphoma.

This latest designation is the fourth that Keytruda has received from the FDA, who has also granted it breakthrough status for specific patients with advanced melanoma, advanced non-small cell lung cancer, and advanced colorectal cancer.

FDA accepts biologics license application for MSD’s allergy immunotherapy drug

MSD (NYSE: MRK) has announced that the US Food and Drug Administration has accepted for review the biologics license application for MK-8237, its sublingual allergy immunotherapy (SLIT) tablet for house dust mite allergies.

This application heavily draws on two Phase III clinical trials, involving more than 4,000 patients, which evaluated the efficacy and safety of MK-8237 in house dust mite-induced allergic rhinitis with or without conjunctivitis.

Gilead must pay MSD $200m in hep C drug patent case

A Californian federal jury has ordered Gilead Sciences to pay MSD and Ionis $200 million for infringing on patents relating to hepatitis C drugs Solvadi and Harvoni.

The amount however, falls far short of analysts’ expectations. When the jury ruled earlier this month that MSD’s patents were valid, it had been thought that the damages payable could amount to as much as $2 billion.

The $200 million is nowhere near the 10% royalties of US sales MSD had sought, and the award covers sales from 2013-2015 for the drugs, which amount to some $23.1 billion.

MSD teams up with Harvard to develop new leukaemia treatments

MSD has entered a new collaboration with Harvard University aimed at developing innovative new small-molecule therapeutics for leukaemia and other cancers.

The compounds, developed in the laboratory of Harvard scientist Matthew Shair, target enzymes that regulate transcription (the process by which DNA is copied).

Federal jury rules in MSD’s favour in Gilead blockbuster hepatitis C drug dispute

Gilead’s dominance of the hepatitis C market is under severe threat after a federal jury ruled in favour of MSD and Ionis Pharmaceuticals, who claimed to hold crucial patents related to sofosbuvir, a compound key to Gilead’s global hepatitis C drug sales of $19 billion last year alone.

New manufacturing boss for MSD

Published on: 10/03/16

MSD has appointed Sanat Chattopadhyay president of the Merck Manufacturing Division (MMD) and an executive vice president of the company. From April 1, he will succeed will succeed Willie Deese, who is to retire on June 1, 2016, after 12 years with the company.

Chattopadhyay is credited with leading MSD out of a troubled period when the company experienced manufacturing issues in its vaccines division, including years of supply limitations with its Shingles vaccine, and MSD describes him as “instrumental” in transforming and growing this part of the business.

MSD joins charity-industry partnership Dementia Consortium

The Dementia Consortium has welcomed MSD into the fold as a new partner in its global venture to accelerate drug discovery for neurodegenerative disease.

Sanofi Pasteur and MSD end European vaccines partnership

Sanofi Pasteur and MSD have announced that they will end their joint vaccines operations in Europe, bringing an end to a collaboration spanning three decades on the Sanofi Pasteur MSD joint venture.

The companies say they will instead integrate their respective European vaccine businesses into their operations, independently manage their product portfolios and pursue their own distinct growth strategies in Europe.

CHMP recommends Sanofi’s two-dose schedule HPV vaccine

Sanofi Pasteur’s and MSD’s vaccine against human papillomavirus (HPV), Gardasil 9, has received a positive opinion from the European Medicine Agency’s Committee for Medicinal Products for Human Use (CHMP).   

The Committee recommended a two-dose schedule in boys and girls aged nine to 14 for the vaccine, which is marketed in western European countries by Sanofi, and by MSD in other countries including the US and eastern European nations.

MHRA approves new indication for MSD’s Ezetrol

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has approved a new indication for MSD’s Ezetrol (ezetimibe), making it available to patients with coronary heart disease (CHD) and a history of acute coronary syndrome (ACS), added to or begun alongside statin therapy. 

“This is great news, particularly for our patients, because many with coronary heart disease continue to have cardiovascular events, even when managed with statins at higher doses and even with conventional

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